ACTRN12621000507886招募中2 期
A single arm, open label, signal seeking, phase II trial of the activity of Durvalumab in combination with Acalabrutinib in patients with high-grade B cell lymphoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Adults aged 18 years and older, with high grade B cell lymphoma or transformed low-grade B cell lymphoma that is refractory to, or relapsed following standard chemotherapy or radiation therapy. There are no limits to the number of lines of chemotherapy the patient may have received. Transplant eligible patients may be included on the study provided that a response assessment is possible after 3 months of therapy.
- •2. Review by the molecular tumour board (MTB). No specific actionable mutation is required for study entry. The MTB will review the clinical information, histology and tissue sample suitability, and will provide a tumour sequencing report. A preliminary recommendation may be issued where clinically relevant.
- •3. ECOG performance status less than or equal to 2.
- •4. Received and failed a standard anti-cancer therapy, or have documented unsuitability for any further standard therapy, if standard therapy exists.
- •5. Clinical or radiological measurable disease that qualifies as a RECIL target lesion at baseline. CT, PET or MRI must be performed within 21 days prior to registration. If there is no radiological measurable disease, percentage bone marrow infiltration or circulating lymphoma cells may be used as a surrogate for measurable disease.
- •6. Adequate organ system function as assessed by the following minimal laboratory requirements (within 7 days prior to first administration of study drug):
- •a. bone marrow function; platelets greater than or equal to 75 x 10^9/L, ANC greater than or equal to 1.0 x 10^9/L
- •b. liver function; ALT/AST less than or equal to 2.5 x ULN and total bilirubin less than or equal to 1.5xULN; Patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of haemolysis or hepatic pathology) are allowed after consultation with their physician and discussion with study PI.
- •c. renal function; Serum creatinine clearance greater than 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance.
- •7. Sufficient and accessible tissue (less than 90 days old) for PD-L1 immunohistochemistry assay and exploratory objectives.
- •8. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
- •9. Signed, written informed consent to participation in the specific treatment substudy
- •10. Life expectancy of at least 12 weeks.
- •11. Body weight greater than 30kg.
排除标准
- •1. Contraindications to investigational product
- •2. Known history of hypersensitivity to active or inactive components of investigational product
- •3. Previous treatment with a PD1/PD-L1 inhibitor or a Bruton’s kinase inhibitor
- •4. Specific co-morbidities or conditions (e.g. psychiatric) or concomitant medications which may interact with the investigational product(s) as assessed by the treating physician.
- •5. Co-morbidities or conditions that may compromise assessment of key outcomes or in the opinion of the treating physician, limit the ability of the patient to comply with the protocol; including clinically significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure (LV ejection fraction less than 40%), or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart association Functional Classification. Note: Subjects with controlled, asymptomatic atrial fibrillation can enrol on the study
- •6. Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment:
- •a. Radiation therapy, surgery, or tumour embolization within 14 days prior to the first dose of study treatment. Palliative radiotherapy (for analgesia) is acceptable only if the irradiated field does not include target lesions.
- •b. Chemotherapy, biologic therapy, or hormonal therapy within 14 days or 5 half-lives of a drug prior to the first dose of study treatment or until recovery from previous therapy (whichever is longer); Concurrent use of hormonal therapy for non-cancer related conditions (eg. Hormone replacement therapy) is acceptable.
- •c. Prior allogeneic transplant (haematopoietic or solid organ)
- •d. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
- •7. Any unresolved toxicity (greater than CTCAE grade 2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripheral neuropathy).
- •8. History of primary immunodeficiency.
- •9. Administration of any investigational treatment within 30 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study treatment.
- •10. Mean QT interval corrected for heart rate (QTc) greater than or equal to 470ms calculated from 3 consecutive electrocardiograms (ECGs) within 15 minutes, 5 minutes apart using Fredericia’s Correction.
- •11. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or acalabrutinib. Exceptions include intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (e.g. less than or equal 10 mg/day of prednisone or its equivalent); use of dexamethasone up to 4mg /day, and steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication).
- •12. Active autoimmune disease or prior documented autoimmune or inflammatory disease including inflammatory bowel disease (e.g. colitis or Crohn’s disease), diverticulitis, systemic lupus erythematomus, Sarcoidosis syndrome, Graves’ disease, rheumatoid arthritis, hypophysitis and uveitis requiring systemic treatment within the past 2 years. Subjects with vitiligo, alopecia, hypothyroidism, or psoriasis not requiring systemic treatment (within the past 2 years) are eligible.
- •13. Uncontrolled intercurrent illness incl
研究者
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